Kyverna Therapeutics Reports Positive Phase 2 Data for Autoimmune CAR-T Therapy
Kyverna Therapeutics reports positive long-term follow-up results for its CAR-T therapy miv-cel in generalized myasthenia gravis, with plans to submit a biologics license application in the first half of 2026. The company has $279.3 million in cash providing runway into 2028 to fund launch and Phase 3 trials.
Kyverna Therapeutics has announced positive long-term follow-up results for its candidate therapy miv-cel (KYV-101) in a phase II clinical trial for generalized myasthenia gravis. The company expects to submit a biologics license application in the first half of 2026 and plans a commercial launch by year-end 2026, supported by $279.3 million in cash and marketable securities providing runway into 2028.
Data show that the therapy continues to demonstrate good safety and tolerability during the extended observation period, while key efficacy indicators maintain a stable trend of improvement. This progress provides an important foundation for the design and advancement of subsequent pivotal clinical trials and also strengthens industry confidence in the potential of this cell therapy.
The company reported its fourth-quarter and full-year 2025 financial results alongside the business update. Key clinical highlights include statistically significant stiff person syndrome registrational topline results, positive interim KYSA-6 generalized myasthenia gravis data with Phase 3 enrollment started, and encouraging investigator-led progressive multiple sclerosis and rheumatoid arthritis results. The registrational stiff person syndrome topline showed statistically significant benefit and no high-grade cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome.
Full-year net loss was $161.3 million in 2025, up from $127.5 million in 2024. Full-year research and development and general and administrative expenses increased to $133.7 million and $36.1 million, respectively, reflecting higher development and operating spend. The company raised $147.5 million through financings and closed a $150 million loan facility with an initial $25 million funded.
Kyverna Therapeutics is a late-stage clinical biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases. The company is advancing what it calls a first-to-market autoimmune CAR T opportunity in stiff person syndrome with key launch preparation activities underway. Enrollment is progressing for an FDA-aligned Phase 3 trial in generalized myasthenia gravis, with the first patient already enrolled.